US11013420B2 - Systems, apparatuses and methods for determining blood pressure - Google Patents

Systems, apparatuses and methods for determining blood pressure Download PDF

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US11013420B2
US11013420B2 US15/117,168 US201515117168A US11013420B2 US 11013420 B2 US11013420 B2 US 11013420B2 US 201515117168 A US201515117168 A US 201515117168A US 11013420 B2 US11013420 B2 US 11013420B2
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arterial
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patient
pulse
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Rafi Ravid
Uriel Weinstein
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Zoll Medical Israel Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02125—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • A—HUMAN NECESSITIES
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    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
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    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
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    • A61B5/0507—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  using microwaves or terahertz waves
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    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
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    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
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    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
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    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
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    • A61B5/7235—Details of waveform analysis
    • A61B5/725—Details of waveform analysis using specific filters therefor, e.g. Kalman or adaptive filters

Definitions

  • Embodiments of the current disclosure are directed toward blood pressure measurement, and more particularly, systems and methods for blood pressure measurement utilizing electromagnetic radiation/waves.
  • Radio-frequency (RF) electromagnetic radiation has been used for diagnosis and imaging of body tissues, examples of which may be found in PCT publication no. WO2011/067623, US publication nos. 2009/0299175 and 2009/0240133, and U.S. Pat. Nos. 4,926,868 and 5,766,208.
  • WO 2011/067623 is understood to be directed to a diagnostic apparatus that includes an antenna, which directs RF electromagnetic waves into a living body and generates signals responsively to the waves that are scattered from within the body.
  • US patent publication no. 2009/0240133 is understood to be directed to a radio apparatus and method for non-invasive, thoracic radio interrogation of a subject for the collection of hemodynamic, respiratory and/or other cardiopulmonary related data.
  • US patent publication no. 2009/0299175 is understood to be directed to a method and apparatus for determining and tracking the location of a metallic object in a living body, using a radar detector adapted to operate on a living body.
  • 4,926,868 is understood to be directed to a method and apparatus for cardiac hemodynamic monitoring based on the complex field amplitudes of microwaves propagated through and scattered by thoracic cardiovascular structures, particularly the heart chambers, as a function of time during the cardiac cycle.
  • Embodiments of the present disclosure present methods, systems and apparatuses techniques for continuous Non-Invasive Blood Pressure (cNIBP) measurement are discussed in the present disclosure (in some embodiments, such measurements may be non-continuous).
  • cNIBP measurements may be accomplished by determining, for example, Pulse Wave Velocity (PWV), which can be used as, for example, a measure of arterial stiffness.
  • PWV Pulse Wave Velocity
  • PWV corresponds to the velocity of propagation of the arterial pressure pulse between points along the arterial tree, which may depend on, amongst other things, the blood pressure. Accordingly, determination of PWV and/or the pulse transit time (PTT) between points along the arterial tree may provide information on the blood pressure in the arteries.
  • one or more sensors may be used to determine the PTT, and/or the pulse wave arrival time, which may also be referred to as the pulse arrival time (PAT), which may be different from the PTT.
  • PTT pulse arrival time
  • sensors such as an electrocardiogram (ECG) device and a photo-plethysmograph (PPG)
  • the PAT may correspond to the delay between the ECG's QRS peak (e.g., R-peak) and a point on the PPG signal representing the pressure pulse at a peripheral artery.
  • ECGs electrocardiogram
  • PPG photo-plethysmograph
  • the RF sensor allows for determination/estimation of the arterial pulse waveform which may provide clinical information such as, but not limited to, arterial stiffness, PWV, cardiac output, cNIBP measurements, etc.
  • an apparatus and a method for measuring time-varying radar cross section (RCS) of an artery of a patient comprises a RF transceiver for generating RF waves, at least one sensor configured for positioning on or adjacent the skin of a patient, and at least one of transmitting the RF waves into tissue of the patient and receiving RF wave reflections from at least one artery located within the tissue.
  • the at least one sensor comprises at least one antennae. In some instances, it may be configured with flexibility that allows the sensor to conform to the skin of the patient.
  • the apparatus also comprises a processor having computer instructions operating thereon configured to cause the processor to execute some or all steps of the method disclosed herein. The steps of the method comprise determining an RF arterial pulse waveform based on the received RF wave reflections, where the time-varying RCS comprises the RF arterial pulse waveform.
  • the method also comprises the steps of correlating the time-varying RCS to a time-varying diameter of the at least one artery, conditioning the RF arterial pulse waveform using at least one radar echo from a specific range, and adapting the specific range to the at least one artery.
  • the steps also include conditioning the RF arterial pulse waveform using band pass filtering, and determining a time location of at least one of a peak of the RF arterial pulse waveform, the first derivative peak, and other points marking an RF-arterial-pulse-arrive-time (RE-PAT).
  • the methods include the steps of characterizing the RF arterial pulse waveform. For example, characterizing may comprise determining a timing of the dicrotic notch of the waveform.
  • the apparatus comprises an ECG sensor configured for positioning on the body of the patient for receiving signals corresponding to an ECG waveform, where signals from the ECG sensor are synchronized with the RF wave reflections.
  • the method includes determining arterial-pulse-arrival-time (PAT) based on a time difference between the RF-PAT and an R-peak of the ECG waveform.
  • the apparatus may also comprise an ECG sensor configured for positioning on the body of the patient for receiving signals corresponding to an ECG waveform. Further, the apparatus may include the at least one sensor positioned to receive RF wave reflections from the aorta of the patient, where signals from the ECG sensor are synchronized with the RF wave reflections.
  • the method may comprise the step of determining an R-peak of the ECG waveform, and determining a time difference between the RF-arterial-pulse-arrival-time (RF-PAT) and the R-peak to determine a pre-ejection period (PEP).
  • the computer instructions may be further configured to cause the processor to determine PTT, where PTT is determined by subtracting PEP from PAT.
  • the at least one sensor may be configured for sensing RF wave reflections corresponding to PAT to each of two different arterial tree locations.
  • the method includes the step of determining the PAT at each location and determining the difference between the PAT at the two locations so as to determine a PTT.
  • the two different arterial tree locations may be discerned based on depth resolution of the tissue.
  • the apparatus may comprise a second sensor, where the first sensor is configured for sensing RF wave reflections corresponding to PAT at a first arterial tree location, and where the second sensor is configured for sensing signals corresponding to PAT at a second arterial tree location.
  • the method includes determining the PAT at each location and determining the difference between the PAT at the two locations so as to determine the PTT.
  • the first arterial tree location and the second arterial tree location comprise different locations on the same arterial tree.
  • the first arterial tree location and the second arterial tree location comprise different arterial trees.
  • the first arterial tree location and the second arterial tree location may comprise different arterial trees on different areas of the body of a patient.
  • the method comprises the step of utilizing an EGG waveform of the patient to synchronize the first and second sensors. Further, it includes gating the time measurement between the first and second sensors, where one sensor gates the measurement of the other.
  • the second sensor comprises a photo-plethysmograph (PPG) sensor or an RF sensor.
  • the method includes the step of determining the patient's blood pressure as a function of PTT, where parameters used to determine NT are calibrated for the patient.
  • the method includes determining arterial PWV, where PWV equals the propagation distance of the arterial pulse wave divided by PTT.
  • FIGS. 1A-B shows an example embodiment of determination of the pre-ejection period (PEP) from electrocardiogram and radio-frequency signal measurements.
  • PEP pre-ejection period
  • FIG. 2 shows a diagram depicting an example arterial pulse waveform.
  • FIG. 3 shows the measurement of arterial pulse waveform from a changing (e.g., time-varying) radar cross section of an artery during cardiac pressure cycle.
  • FIG. 4 illustrates an example placement of radio-frequency sensors over the thorax.
  • FIG. 5 depicts an example schematic diagram of the components of the apparatus for measuring time-varying radar cross section (RCS) of an artery disclosed herein.
  • RCS radar cross section
  • RF sensors e.g., antenna
  • the RF signal waveform can be continuous or based on step frequency.
  • the signals may have a wide range of frequencies, for example, the RF frequency may range from about 300 MHz to about 3 GHz.
  • the RF sensor can achieve a range (e.g., depth) resolution that allows filtering of reflections from relevant depth in a patient's body.
  • the sensor may allow penetration of a few centimeters into the body, facilitating its usage for a variety of arteries (e.g. anterior tibial, popliteal, brachial, carotid, etc.).
  • the RF sensors may be used in conjunction with other sensors/devices, such as (for example) an ECG sensor/device and/or a PPG sensor, to determine PTT and/or PAT of a pulse wave in an artery.
  • sensors/devices such as (for example) an ECG sensor/device and/or a PPG sensor, to determine PTT and/or PAT of a pulse wave in an artery.
  • PEP Pre-Ejection Period
  • the effects of the PEP may be significant in determining blood pressure levels.
  • the PWV may then be calculated based on the distance the pulse traveled to arrive at the point and the estimated/determined PTT.
  • blood pressure values such as systolic and/or diastolic values can be determined non-invasively from the PWV and/or the PTT.
  • other types of transformations may be used to calculate blood pressures.
  • obtaining PTT, or conversely PWV of a pulse in an artery may lead to the determination of blood pressure levels in the artery.
  • RF waves may be used to locate the time of the opening of the aortic valve.
  • the reflected electromagnetic signal (with sensors located in the appropriate place, and optionally after appropriate filtering) may provide information on the opening of the aortic valve, and hence can be used in conjunction with the ECG signals that represent the activation of the ventricles, for determining the PEP.
  • PAT can be found by comparing the simultaneous detection of ECG signals to that of the PPG signals, which represent the activation of the pulses at the ventricles and arrival of the pulses at the peripheral arteries, respectively.
  • the comparison may correspond to the delay between the ECG's QRS peak (i.e., R-peak) and a point on the PPG signal representing the pressure pulse at a peripheral artery.
  • one or more PPG sensors may be located near a peripheral artery (e.g., finger, ear-lobe, etc.), and one or more RF sensors (e.g., antenna) may be located so that the antennae receives reflections from the heart, for example, at the sternum.
  • the heart signals can be isolated by a combination of range and Doppler filtering of the RF signals.
  • the RF signal may be filtered to isolate heart reflections from the relevant depth, and may also be filtered to remove reflections from static objects.
  • the R-peak time may be determined from the ECG signals.
  • FIG. 1 shows an example embodiment of PEP correction estimation 103 from the time difference between the ECG R-peak 102 and the RF signal pulse 101 .
  • the RF sensor can be utilized to obtain the arterial pulse waveform, which may provide clinical information such as, but not limited to, arterial stiffness, PWV, cardiac output, cNIBP measurements, and the like.
  • the sensor may scan the cross section of objects in its view, which may include an artery.
  • the RF sensor may measure the changing radar cross section of the artery.
  • the changing arterial cross section is related to the pulse wave, and accordingly the arterial pulse waveform maybe determined from the changing cross section.
  • An example arterial pulse wave 201 obtained using this method is depicted in FIG. 2 . This method has several advantages in that in obtaining the arterial pulse waveform, it is at least non-invasive, allows penetration into the body, and/or can be operated with little or no expertise.
  • FIG. 3 shows the measurement of arterial pulse waveform from a changing (e.g., time-varying) RCS of an artery during cardiac pressure cycle, according to some embodiments.
  • an RF radar sensor 301 may generate and transmit RF waves 303 towards an artery 302 which may be located at a certain depth from the RF sensor 301 corresponding to a measurement range 306 a .
  • some or all of the transmitted waves 303 may be reflected back to the RF sensor 301 .
  • the RF sensor 301 may transmit the RF waves 303 continuously or non-continuously.
  • the diameter of the artery 302 may be varying over time, e.g., 305 a and 305 b , and as a result the RCS of the artery 302 obtained by the RF sensor 301 changes over time as well.
  • an arterial pulse waveform 304 representing the pulse wave propagating through the artery may be determined.
  • a variety of clinical information such as but not limited to arterial stiffness, PWV, cardiac output, blood pressure measurements (continuous or non-continuous) may be obtained.
  • the reflected echo may be modulated by the artery over the course of the cardiac cycle, and information from the reflected echo can be used to determine/estimate the arterial pulse waveform 304 .
  • the measurement range 306 a may change over the course of the cardiac cycle (e.g., 306 a and 306 b ), leading to changes in the phase of the reflected waves. In such instances, such information can be utilized to determine/estimate the arterial pulse waveform 304 .
  • RF waves may be used to determine the PAT.
  • the ECG signals represent the activation of the ventricles, i.e., the onset of the pulse wave.
  • a determination of the arrival of the pulse at a location on an artery may allow for an estimation/determination of the PAT by comparing the ECG signals with time of arrival for the pulse.
  • the location may be at a peripheral artery (e.g., fingers, ear lobes, etc.).
  • the location may be at a depth inside a body, which as discussed above is one advantage of using RF signals.
  • the RF sensor can be located in a variety of places on the body, which allows for the ability of the RF waves to penetrate into a particular depth into the body. In some embodiments, this may allow for choosing an artery for observation (i.e., not necessarily in the finger or earlobe).
  • the RF reflections may be used to identify the time of arrival of the pulse wave to the chosen artery, and the PAT may be determined from the time difference between the ECG R-peak and the RF signal pulse arrival time.
  • the PTT of the pulse can be determined if the times of arrival of the pulse at two distinct locations can be measured. This follows because the PEP values of the pulse that originated at the same ventricle but arrived at the two different locations is the same, and accordingly, the difference in PAT for the two locations is the same as the difference in PTT of the pulse to the two distinct locations.
  • FIG. 4 shows two RF sensors 401 and 402 located at different positions on the body (e.g., the sternum and the thorax, two suitable locations along the leg, etc.) can be used to sense the pulse wave going through arteries close to each RF sensor.
  • the RF sensors may be incorporated into clothing (e.g., stockings, shirts, etc.), chest straps, wrist straps, skin patches, and/or the like.
  • the RF signal may be filtered to isolate the reflections from the relevant depth and to remove reflections from static objects.
  • the PTT may be determined as the time difference between the pulse wave arrival times as measured by the two RF sensors. It is worth noting that the two RF sensors, in some embodiments, may be synchronized. An example way to achieve synchronization may be by using two ECG sensors, where the R peak can be viewed as the synchronizing marker.
  • the PTT of the pulse can be determined if the times of arrival of the pulse at two distinct locations can be measured.
  • the two locations were disclosed to be at the peripheries of arteries, for example, at the sternum and the thorax, at two suitable locations along the leg, etc.
  • both locations may not be on the peripheries of arteries as discussed above. For example, one of them can be at the periphery of an artery, and the other can be at a depth inside the body.
  • two co-located sensors may detect, respectively, an artery located inside the body and a peripheral artery (e.g., on a finger, ear lobes, etc.).
  • the RF sensor may be used to penetrate into the body and reflections from a specific depth in the body can be isolated by processing the RF echoes.
  • the PPG sensor e.g., used in reflective mode
  • the sensors can be located on the thorax, where reflected RF echoes from the lungs (for example) can be isolated, and pulse waves from arteries going through the lung may be measured in this way.
  • the determination of the PTT of a pulse may be accomplished by a single RF sensor if the times of arrival of the pulse at two distinct locations can be measured using the single sensor.
  • the two distinct locations are at peripheries of arteries, and other embodiments where one location is at a periphery of artery and the other at a depth inside the body.
  • the two locations may be inside the body at different depths.
  • the single RF sensor may be located in a position where it receives signals for deciphering different arteries at different depths in the body.
  • the sensor may detect pulse waves arriving at different arteries belonging to different branches at different depths in an arterial tree. In such embodiments, the sensor may measure their arrival times at the different depths, and determine/estimate the PTT from the time difference between the arrival times.
  • FIG. 5 depicts an example schematic diagram of the components of the apparatus for measuring time-varying radar cross section (RCS) of an artery disclosed herein.
  • the apparatus may comprise one or more RF sensors 501 a , 501 b , 501 n . Further, it may also include an ECG sensor 502 configured for receiving signals corresponding to an ECG waveform. In some instances, the apparatus may also contain a PPG device 503 .
  • the devices/sensors such as the RF sensors 501 a , 501 b , 501 n , the ECG sensor 502 , the PPG device 503 , etc., may receive signals from the body of a patient (e.g., from arteries).
  • these sensors/devices may transmit data/information corresponding to the received signals to a processor 504 configured for executing computer instructions to act on the transmitted data/information.
  • the processor 504 may receive other input 505 (e.g., patient data, variables (e.g., temperature, time, etc.), and/or the like), and upon executing computer instructions with some or more of the received input, in some embodiments, the processor 504 may generate outputs 506 such as, but not limited to, arterial pulse waveform, blood pressure measurements, etc. These outputs may be presented via any suitable media (e.g., printer, database, display, audio, and the like).
  • inventive concepts may be embodied as one or more methods, of which an example has been provided.
  • the acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
  • At least some of the embodiments disclosed above, in particular at least some of the methods/processes disclosed, may be realized in circuitry, computer hardware, firmware, software, and combinations thereof (e.g., a computer system).
  • Such computing systems may include PCs (which may include one or more peripherals well known in the art), smartphones, specifically designed medical apparatuses/devices and/or other mobile/portable apparatuses/devices.
  • the computer systems are configured to include clients and servers.
  • a client and server are generally remote from each other and typically interact through a communication network (e.g., VPN, Internet). The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
  • Some embodiments of the disclosure may be embodied in a computer program(s)/instructions executable and/or interpretable on a processor, which may be coupled to other devices (e.g., input devices, and output devices/display) which communicate via wireless or wired connect (for example).
  • a computer program(s)/instructions executable and/or interpretable on a processor which may be coupled to other devices (e.g., input devices, and output devices/display) which communicate via wireless or wired connect (for example).
  • inventive embodiments may be practiced otherwise than as specifically described and claimed.
  • inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein.
  • any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.
  • Still other embodiments of the present disclosure are patentable over prior art references for expressly lacking one or more features disclosed in the prior art (i.e., claims covering such embodiments may include negative limitations).
  • a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
  • the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
  • This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.
  • “at least one of A and B” can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

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US20210251507A1 (en) * 2014-02-05 2021-08-19 Zoll Medical Israel Ltd. Systems, apparatuses and methods for determining blood pressure
US11883136B2 (en) * 2014-02-05 2024-01-30 Zoll Medical Israel Ltd. Systems, apparatuses and methods for determining blood pressure
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EP3102100A4 (fr) 2017-11-08
US11883136B2 (en) 2024-01-30
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